Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-29 @ 8:28 PM
Study NCT ID:
NCT00639769
Status:
COMPLETED
Last Update Posted:
2012-09-14
First Post:
2008-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
Official Title:
Phase II Trial of Irinotecan Plus Cisplatin in Patients With Recurrent or Metastatic Squamous Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating recurrent or metastatic head and neck cancer.
PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating recurrent or metastatic head and neck cancer.
Detailed Description:
OBJECTIVES:
* Evaluate the efficacy of irinotecan hydrochloride and cisplatin in patients with local-regionally recurrent or metastatic squamous cell carcinoma of the head and neck.
* Evaluate the toxicity of irinotecan hydrochloride and cisplatin in these patients.
* Determine the palliative effect of irinotecan hydrochloride and cisplatin on head and neck cancer symptoms using the Vanderbilt Cancer Center (VICC) Head and Neck Cancer Symptom Survey.
OUTLINE: Patients receive irinotecan hydrochloride IV over 60 minutes and cisplatin IV on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete the Vanderbilt Cancer Center (VICC) Head and Neck Cancer Symptom Survey at baseline, before each course, at the completion of study therapy, and then at each follow-up visit.
After completion of study therapy, patients are followed every 6 weeks for 1 year and then every 3 months thereafter.
* Evaluate the efficacy of irinotecan hydrochloride and cisplatin in patients with local-regionally recurrent or metastatic squamous cell carcinoma of the head and neck.
* Evaluate the toxicity of irinotecan hydrochloride and cisplatin in these patients.
* Determine the palliative effect of irinotecan hydrochloride and cisplatin on head and neck cancer symptoms using the Vanderbilt Cancer Center (VICC) Head and Neck Cancer Symptom Survey.
OUTLINE: Patients receive irinotecan hydrochloride IV over 60 minutes and cisplatin IV on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete the Vanderbilt Cancer Center (VICC) Head and Neck Cancer Symptom Survey at baseline, before each course, at the completion of study therapy, and then at each follow-up visit.
After completion of study therapy, patients are followed every 6 weeks for 1 year and then every 3 months thereafter.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: